Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist

NCT01888744 | Completed Phase 4

• 1 other identifier: 2010/010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).

Conditions

Reproductive Endocrinology; Fertility; Optimal Stimulation Protocol

Keywords

Intracytoplasmic sperm injection (ICSI); PGD; GnrH agonist; GnRH antagonist

Outcome Measures

Primary Outcomes (1)

• Number of day 3 embryos for biopsy available

  up to 6 weeks

Secondary Outcomes (2)

• Number of mature cumulus-oocyte complexes

  up to 6 weeks

• clinical pregnancy rate

  up to 9 months

Study Arms (2)

Group 1 (GnRH agonist group)

ACTIVE COMPARATOR

The long GnRH agonist protocol starts on day 21 of the preceding cycle with the administration of GnRH agonist, Decapeptyl® 0,1 mg subcutaneously daily or buserelin acetate, Suprefact® 600 μg daily intranasal. The administration of highly purified human menopausal gonadotropin (hp-HMG), Menopur® 225 IU subcutaneously is started after three weeks of desensitization. The desensitization is checked by ultrasound (absence of cysts) and hormonal measurement (Estradiol levels \< 80 pg/ml, FSH ≤ 10 IU/l and progesterone \< 1,5ng/ml)

Drug: GnRH agonist; Drug: hP-hMG; Drug: Human chorionic gonadotropin; Drug: Progesterone

Group 2 (GnRH antagonist group)

ACTIVE COMPARATOR

Ovarian stimulation is started at day 2 of the menstrual cycle with 225 IU of HMG (Menopur ®) subcutaneously. At day 6 of the stimulation GnRH antagonist (Orgalutran®) 0,25 mg subcutaneously is added. Basal hormonal status will be confirmed in the antagonist group before starting.

Drug: GnRH antagonist; Drug: hP-hMG; Drug: Human chorionic gonadotropin; Drug: Progesterone

Interventions

GnRH agonist DRUG

Also known as: Suprefact nasal spray

Group 1 (GnRH agonist group)

GnRH antagonist DRUG

Also known as: Orgalutran or Cetrotide

Group 2 (GnRH antagonist group)

hP-hMG DRUG

Also known as: Menopur

Group 1 (GnRH agonist group); Group 2 (GnRH antagonist group)

Human chorionic gonadotropin DRUG

induction of final oocyte maturation

Also known as: Pregnyl

Group 1 (GnRH agonist group); Group 2 (GnRH antagonist group)

Progesterone DRUG

Also known as: Utrogestan vaginal tablets

Group 1 (GnRH agonist group); Group 2 (GnRH antagonist group)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≤ 39 years the day of oocyte retrieval
• BMI ≤ 29
• cycle rank 1
• menstrual cycle 25-36 days
• PGD or preimplantation genetic screening (PGS) requested
• ICSI
• Single embryo transfer (SET) on day 5

You may not qualify if:

• Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria)
• Hormonal disturbances
• Endometriosis grade III and IV

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Centre for Reproductive Medicine

Brussels, 1090, Belgium

Location

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; ganirelix; cetrorelix; Menotropins; Chorionic Gonadotropin; Progesterone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Gonadotropins, Pituitary; Gonadotropins; Pituitary Hormones, Anterior; Pituitary Hormones; Biological Products; Complex Mixtures; Placental Hormones; Pregnancy Proteins; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 28, 2013
• Study Start: September 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

BE (1)